PSGR supports the members Bill that amends the Environmental Protection Authority Act 2011 (EPA Act) to add an additional objective that the organisation must aim to protect, maintain, and enhance New Zealand's environment.

Physicians and Scientists for Global Responsibility is a Charitable Trust representing medical and scientific professionals and serving the public’s right to be independently informed. We will not be speaking to this submission.

1. Terminator gene technology

1.1. There has been such strong debate and objection internationally against the variants of terminator gene technology being used that a virtual voluntary moratorium is in place. If this Application to ERMA is approved, Scion – and thus New Zealand – will be seen to dishonour the decision made by countless scientists and countries worldwide to protect and maintain the integrity of Earth’s ecosystems.

1.2. Worldwide, a majority of scientists and members of the public believe terminator technology is dangerous. Most scientists dismiss the claims that the technology is an incentive to the development of new plant varieties. In respect of trees, they claim the disadvantages are:

The variants of terminator technology offer no absolute guarantee of sterility,

The potential horizontal gene transfer of the terminator trait to cultivated plants, or to wild plants;

The presumption of entitlement by developers;

The undermining of tree crop security.

We refer you also to “New Zealand Out in Front on GM Sterile Seeds” released by the Sustainability Council of New Zealand.

1.3. The claim is that trees developed using terminator technologies employ anti-sense genes or small regulatory RNA to prevent active gene products from being formed. Also employed is a kind of genetic abortion using a ‘suicide’ gene. This could be the barnase ribonuclease gene from the soil bacterium Bacillus amylolquefaciens, which is controlled by a promoter specific to floral or pollen development. Once activated, the gene product kills the cells in which the gene is expressed.

1.4. However, scientists at Sopanen University, Finland, have studied the control of flowering in silver birch trees, using a flower specific birch promoter gene, BpMADS1, to drive the barnase gene. They found that floral cell ablation prevented flowering, but that this had side effects to leaves and branching. These side effects may have been a pleiotropic effect of the gene insertion and the pleiotropic effects seen may extend into areas not yet detected.

1.5. The ablation toxins used in creating sterile trees present dangers: e.g. barnase ribonuclease has proved toxic to the kidneys in rats; and barnase was cytotoxic in mice and human cell lines.

1.6. Even if totally sterile, terminator trees can spread by asexual means. The genes can spread horizontally to soil bacteria, fungi and other organisms in the extensive root system of the forest trees, which in turn could have unpredictable long-term impacts on the soil biota and fertility.

1.8. Transgenic traits tend to be unstable. They can break down, revert to flower-development, and potentially spread transgenes to native trees. They could create pollen that poisons bees and other pollinators as well as causing potential harm to human beings.

1.9. Trees that do not flower and fruit cannot provide food for the insects, birds and mammals that feed on pollen, nectar, seed and fruit. Local flora would thus lose pollinating insects in areas where transgenic trees are grown. This would inevitably have undesirable impacts on biodiversity, particularly in large areas of monoculture forests. The ability of an ecosystem to recover from disturbance and re-establish its stability, diversity and resilience would be damaged, possibly permanently.

1.10. Pleiotropic effects from the gene insertion may be immediately seen or may extend into areas not easily detected. There is little knowledge of how these effects would affect soil bacteria.

1.11. Sterile monocultures are known to yield more readily to disease or senescence, which in turn has the potential to devastate entire plantations over huge areas.

2.1. Testing of transgenic developments is almost always inadequate, with a reliance on industry/developer test results, and oversight of field trials is almost always scant or non-existent. Independent analysis and assessment is extremely rare. Vested interests dominate.

2.2. A partner in this proposed development is ArborGen LLC. Their Application No. 06-325-111r was made to the US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS). It sought approval to continue field-testing transgenic Eucalyptus trees that may flower. The trees were cloned from a hybrid of Eucalyptus grandis X Eucalyptus urophylla, and engineered with three gene constructs; two that confer cold tolerance, one to reduce flower development.

2.3. This field test was originally planted under APHIS Notification 05-256-03r, a permit for Eucalyptus grandis, not the hybrid given on the current Application 06-325-111r. The question was then asked, was the Application to “continue field testing” valid?

2.4. In July 2006, ArborGen, having been charged with failure to maintain the identity of trees in their test plots, were directed to remove the trees, and US Federal Courts ruled against the USDA in three cases for failing to carry out proper environment impact assessment, thus making the original approvals illegal.

(See ‘A Silent Forest: The Growing Threat, Genetically Engineered Trees’ (44 min. DVD) discusses the threats posed by transgenic trees to the environment and to human health; narrated by Professor Emeritus, David Suzuki, an internationally respected geneticist, recognized as a world leader in sustainable ecology.

3. The economy, the environment and employment

3.1. This Application claims it will develop many thousands of experimental GE trees using a wide variety of genetically engineered experimental options. Numerous media reports have shown that Scion’s handling of the environmental effects at its transgenic trees field trial sites have been inadequate and irresponsible. Further, the research pertaining to these trials has not been academically peer reviewed or published. Scion’s actions do not suggest a creditworthy or trustworthy attitude to its obligations.

3.2. New Zealand’s Pinus radiata forests have been developed over more than 150 years using highly efficient, selective breeding. The reward is a major export earner that plays a dominant role in the New Zealand economy. In ‘Comparative Study of NZ Pine’ it is predicted that the total New Zealand forest harvest of Pinus radiata will be 35 million cubic metres by 2015. Any damage caused by the experimental trees could be significant and adversely affect the environment, employment and exports.

3.3. To New Zealand’s GDP, the forest industry contributes approximately 4%, and just under 12% of the merchandise trade by value. It employs just under 1.5 % of the labour force. Any damage to this industry by the very real potential adverse effects of using gene or terminator technology would have substantial effects.

(Statistics New Zealand www.stats.govt.nz; Ministry of Agriculture and Forestry www.maf.govt.nz).

3.4. Because introduced genes can be unpredictable, unforeseen traits can develop and be passed on to future generations. The damage would be irreparable. Accountability would be impossible to police.

3.5. Where multiple traits are introduced into a new host – gene stacking – it cannot be predicted how stable each introduced gene will be, or how predictable or stable the development of the combination of introduced genes will be.

3.6. There will be environmental impacts if we replace diverse native forests with monoculture tree plantations. Transgenic trees could impact on local flora and fauna in ways that cannot be adequately predicted.

3.7. See 1.9.

4. Pollen drift

4.1. We read the risk of pollen drift being understated in the Application, despite this being the most obvious risk. Also, looking at Scion’s past practice, high risk is likely. Pollen particles can be so small they are invisible to the human eye. Containment in the open environment is neither practical nor possible.

4.2. We remind ERMA of its statement made in respect of Plant & Food’s transgenic brassica Application. Despite ERMA’s assessment to the contrary, pollen escape did happen.

4.3. We also remind ERMA that pollen catkins have appeared on inadequately managed transgenic tree seedlings at Scion’s Rotorua site.

4.4. The New Zealand Forest Research Institute at Rotorua says security measures to stop cross-pollination include a buffer zone around the pine trees. However, pollen from transgenic trees could travel long distances. A study undertaken in India established that pollen from pine trees travelled over 600 kilometres (Sing et al, 1993).

4.5. Once in the upper atmosphere, pollen can travel huge distances. Nothing can protect a country’s ecosystem from pollen being blown across borders and contaminating native or commercial species.

4.6. It would need a failure rate of only part of a percent for transgenes to contaminate other trees, potentially at large distances, in ways that could not easily be monitored.

4.7. Pollen from transgenic trees and their introduced DNA would become untraceable.

4.8. There is potential for elements of terminator constructs to spread horizontally to other forest trees, affecting their fertility. Researchers have found that the dispersal or gene flow of pollen and seeds from forest trees can be measured in kilometres, and potentially hundreds or thousands of kilometres. Once released, transgenes from transgenic trees cannot be contained and pose serious threats to the integrity of forest ecosystems. The claim by developers that the solution to this problem is ‘terminator’ techniques that prevent flowering or pollen production does not stand up to scientific scrutiny.

5. Ethics, safety and the inadvisability of approval of this application

5.2. The respondents saw consumer rejection and the cost of trials, intellectual property rights and regulations, as obstacles to their research.

5.3. They saw the perceived benefits as requiring years of costly biological and environmental assessment before commercialization is practical.

5.4. A final conclusion of the survey responses was that traditional forestry biotechnology - i.e. research and development that excluded genetic engineering technology - is less costly and requires less regulation.

5.5. Any proposed safety assessment framework for transgenic trees must acknowledge the diversity of existing forests and recognize the benefits of multiple uses of forests that conserve diversity.

5.6. PSGR Trustee, Dr Elvira Dommisse is a geneticist. Speaking on the genetic engineering of pine trees, she says: “That does not mean that the same gene which has been genetically engineered into another species in an artificial gene construction will be harmless. It is in part true, but we cannot conclude from this that all is well. In its genetically engineered form, the gene is no longer under the control of its own DNA. It may well be a synthetic modified version of the original gene and is jammed into a complicated construct made up of bits of DNA from a number of different organisms. This means the gene is always switched on and is engineered to produce large amounts of a protein or proteins that pine trees don't normally make. The cellular machinery of a pine tree may produce a protein or proteins that are different from those used in the GE process. Such altered proteins can be harmful. This has already happened in genetically engineered peas, when a harmless bean protein became a toxin when engineered into the closely related pea.”

5.7. Because safety testing of anything produced using genetic engineering technology is generally left to the developer, the confidence of scientists and the public in the process is low. There is a very urgent need for independent oversight and safety testing of all experimentation using the genetic engineering technologies.

5.8. Pierre Sigaud, an expert in forest genetics at the UN’s Food and Agriculture Organization (FAO), has warned against rushing into growing transgenic trees commercially before running environmental risk assessments according to national and international protocols: “The issue goes beyond country level since pollen flow and seed dispersal do not take account of national boundaries and wood is a global commodity.”

5.9. At the United Nation’s Convention on Biological Diversity (CBD) in Curitiba, Brazil, in March 2006, a formal declaration was passed to recognize the threats posed by genetically engineered trees. It urged all countries to approach the technology with caution. This declaration supported the FAO’s 2005 call for an international framework to assess the safety of GM trees.

6.1. As has been shown overseas with herbicide tolerant transgenic crops, herbicide resistance has exacerbated the use of herbicides. There is no scientific evidence to suggest that this would not happen in New Zealand if Scion’s Application is approved.

6.2. Growing transgenic, herbicide-resistant crops has led to an increasing number of weeds becoming resistant, forcing farmers to apply greater amounts of weedkiller. The most common resistance is to glyphosate. Gene stacking (resistance to multiple herbicides) was reported in Canada’s Globe and Mail (15 June 2000) a mere five years after the commercialization of transgenic crops. Chemical and DNA tests confirmed canola volunteers (self-sown seedlings growing wild) were resistant to Roundup, Liberty and Pursuit herbicides.

6.3. In Australia, ryegrass is a problematic weed and also a valuable pasture plant. In 1997, Monsanto Company confirmed that samples of this ryegrass were found resistant to glyphosate, the active ingredient in its herbicide, Roundup. That same year, samples of Malaysian goosegrass, a noxious weed, were also found resistant to glyphosate. This came after herbicide resistant crops being introduced a short time before. It is worth noting that Australia’s annual bill for superweed damage to agriculture and the environment is reportedly AUD$4 billion. Biocontrol agents can be useful, but not always possible.

7.1. We remind ERMA that ArborGen is substantially owned by US interests. The one-third share of ArborGen owned by the New Zealand company, Rubicon, is in itself over 80 percent owned by US interests. The remaining two-thirds of ArborGen are owned by large US companies. The US has reportedly the world’s largest development of transgenic trees. They have a vested interest in this Application.

7.2. This experimentation is not in New Zealand’s best interests. Internationally, overseas interests will see New Zealand as the instigator of a new environmental threat likely to draw a similar response to that given to the initial appearance of Terminator Gene Technology. The adverse economic reverberations could be considerable. A major customer, Japan, does not tolerate transgenic products. European nations are reluctant to accept transgenic products.

7.3. Forestry interests growing conventional trees will see approval of this Application as a threat to their livelihood, as indeed it has the potential to be.

7.4.. The long lifespan of the intended final product, transgenic trees, makes the potential risks all the greater. A forest is its own ecosystem and that ecosystem could be destroyed during the average thirty year lifespan of a pine tree.

PSGR opposes this Application aware that there have previously been several issues of non-compliance by Scion at its Rotorua transgenic field trial site exposed. Approval would not be in the best interests of New Zealand forestry, environment, exports or employment.

Signed by the Trustees of Physicians and Scientists for Global Responsibility by Jean Anderson

PSGR confirms that it wishes to speak to this submission and does not require its details or submission to remain confidential.

This is a collective submission and covers all four Applications identified in the above submission title. This submission also includes a component that addresses AgResearch’s current and interrelated application for a 67A amendment of Parts 1 and 2 of GMF98009. All Applications were posted and became publicly accessible on the ERMA website at about the same time in August 2008.

In summary:

Under this umbrella series of Applications, AgResearch seeks approval to import into containment, organisms with a range of genetic modifications and maintain these organisms in containment for research, breeding and for the production of products with potential commercial Applications (GMC07012)…

AND

to develop in containment outside of a containment structure, organisms with a range of genetic modifications and maintain these organisms in containment for research, and for the production of products with potential commercial Applications (GMD07074)…

AND

to develop within a containment structure, organisms with a range of genetic modifications and maintain these organisms in containment for research, and for the production of products with potential commercial Applications (GMD08012)…

AND

to field test in containment, organisms with a range of genetic modifications and maintain these organisms in containment for research, breeding and for the production of products with potential commercial Applications (GMF07001).

AND

in a fifth application to ERMA, AgResearch has filed a request for a 67A amendment of GMF98009 that is inseparably linked to the four above. It asks for an amendment to existing stipulated controls governing the fate and disposal of unwanted genetically modified livestock and products currently at the Ruakura field livestock containment site when approval lapses in November 2008.

1. In this umbrella series of interacting but sparsely detailed Applications to ERMA, AgResearch’s declared intention is to import any or all of a wide variety of animals, animal cells, embryos, sperm, ova of about nineteen different animals and organisms, most with a range of undeclared or unknown genetic constructs, for the general purpose of research, breeding and production of a commercial smorgasbord of antigens, biopharmaceuticals, enzymes, hormones for commercial release. AgResearch contends that containment facilities, including those for the larger animal genera, may be sited in either the North or South Island and be operational over indefinite periods of time.

AgResearch observes that the existing animal containment unit at Ruakura (integral component of GMF98009 and GMD 02028, capacity of 200 dairy cattle) is currently on leased land close to residential areas. AgResearch is predicting the Ruakura containment facility may not be a likely site for AgResearch’s GE-livestock research activities being foreshadowed in these current Applications, but has provided no compelling justification for the likely rejection of the present containment facility. The sort of GE-livestock farming operations alluded to in their Applications may require approvable containment facilities elsewhere in such geographic areas as Waikato, Taranaki, Canterbury and Southland., A search of the Applications for any justification for the nomination of these provincial regions proved to be pointless.

2. In preparing these several Applications to ERMA, AgResearch has deliberately chosen a presentational style that PSGR considers borders on contempt of the relevant sections of HSNO legislation and therefore the basis of ERMA’s statutory obligations under the HSNO Act.

AgResearch makes it clear that, at least to it, it is unnecessary to provide ERMA with specifically requested information about the specifics of genetic modification of ‘animals, animal cells, embryos, sperm and ova’ cited in their application. PSGR contends that this deliberate exclusion of information precludes the ERMA Authority from foundation material that could enable it to determine and evaluate risks to public health from transgenic livestock maintained or produced as a consequence of these Applications. Realistic assessment of transgenic constructs in terms of risk probability is impossible.

In these Applications, AgResearch has gone so far as to seek approval to specifically import and develop any ‘animal, animal cells, embryos, sperm and ova’ organism that has been, or can be, genetically modified by any available technique known to AgResearch.

In an obvious contradiction of statements made in its Applications to ERMA, AgResearch (p18 of GMD0704) acknowledges that it knows that a prime requirement and purpose of HSNO is to provide ERMA with a detailed ‘organism description’ in Applications.

In this suite of Applications AgResearch has wilfully failed to do so.

3. In a further significant departure from the purpose of the HSNO Act (1996), AgResearch in these Applications is seeking approval of certain methodologies that could allow them to side-step a responsibility under the Act to give full regard to the intrinsic value of ecosystems [S6 (b)]. Not only has AgResearch declared the boundaries of field test definition – the crux of large livestock containment - have not been fully tested, it now openly claims there is no need to treat transgenic waste-materials (like milk) prior to final disposal.

With complete disregard for common environmental responsibilities, AgResearch brazenly proposes, resting on its claimed experience over eight years, that the disposal of GE-animals and wastes from a field containment facility (e.g. Ruakura site) does not now need to be restricted to the field containment site and proposes that disposals be made at off-site (no controls) locations.

With reference to Appendix IX of GMD07074, AgResearch continues to claim that horizontal gene transfer (HGT) of transgenic material to soil microorganisms at the Ruakura offal-pit disposal sites has not occurred. PSGR has every reason to believe that AgResearch methodologies and therefore HGT-detection limits are inadequate. Despite eight years of reported and unvalidated HGT-monitoring of the offal pits at Ruakura, we believe no such conclusion can be claimed to be valid.

The correct conclusion is much clearer and just as conclusive: ‘based on the monitoring work and methodologies reported in Appendix IX of GMD07074, no evidence of HGT occurring has been obtained, though HGT may have occurred but not detected.’

4. In a recent submission (14 August 2008), PSGR submitted to ERMA and the Minister for the Environment the following:

However, before any releases of GMOs occur, we strongly advocate that each formal Application to ERMA that seeks controlled release of a GMO should be required to provide complete scientific documentation of the intrinsic design of each new genetic-construct that enables its detection and identification during relevant HGT and LGT monitoring activities carried out under field conditions. No conditional release approval should be granted by ERMA without the applicant first providing ERMA with this necessarily relevant bio-security information.

Since the overall thrust of AgResearch’s present suite of Applications appears to be towards a potential scenario of commercial GE-livestock operations held under conditional (controlled) release, characterised by contradictory on-site or off-site waste disposal operations from GE-livestock containment facilities, PSGR recommends:

That each formal Application, in this case GMC07012, GMD07074, GMD08012, GMF07001, be required to provide complete scientific documentation of the intrinsic design of each new genetic-construct, either imported or produced by AgResearch, that enables the reliable detection and identification of that genetic construct during relevant HGT and LGT monitoring activities carried out on livestock field containment facilities. No approval should be granted by ERMA without the applicant first providing ERMA with this necessarily and detailed bio-security information.

In view of AgResearch’s current proposal to dispose of GE-livestock wastes off-site using methods that may include ‘incineration, burial, organic waste treatment (commercial or composting or spraying onto pasture)’, PSGR believes AgResearch has a statutory obligation to provide full details of the genetic constructs of all genetically modified organisms to be used, whether new or imported, as an integral feature of each application to ERMA. This way ERMA may reasonably expect AgResearch to be diligent and come forward with details of the monitoring methodologies to be involved that use reporter-gene systems that are realistically capable of in situ detection and quantification of HGT in GE-hotspots such as soil at GE disposal sites.

[Note: Although amendment Applications are usually processed without inviting public comment (i.e. non-notified), this Application is posted on the ERMA website and is bound to attract comment because of its close links to the four other Applications above.]

PSGR considers any assessment of this Application is highly problematical, as the applicants no doubt also appreciate. Should no other appropriate approval plus controls come into existence, then no case exists for a simple transfer of the GE-livestock in question. Because PSGR is recommending that none of the current AgResearch Applications be accepted, this amendment to GMF98009 should also be declined and the controls remain unchanged and approval expiry allowed to take place as authorised.

A significant question has been raised by a particular entry in this Application. Under ‘Reasons Amendment Sought’ section 5.1 of the Application, AgResearch submits, ‘it would wish to continue research and commercial activities with the cattle developed under approvals GMF98009’. To our knowledge, no approvals for GMF98009 were authorised to permit any commercial activity. It is clearly important that details of any undisclosed commercial activities that have actually occurred now be made public by ERMA and AgResearch.

Recommendations of PSGR:

None of the Applications GMC07012, GMD07074, GMD08012, GMF07001, and 67A amendments to GMF98009 Part I and II are to be approved by ERMA for the following reasons:

· The Applications are deficient in fundamental technical information required by ERMA, including details of the molecular characterisation of new organisms and their transgenic constructs to be used in the testing and development of transgenic livestock

· Proposals by the applicants to dispose waste materials from transgenic livestock operations off-site should not be authorised. ‘Off-site’ is taken to mean ‘not in containment’ under HSNO, and includes undocumented geographic locations and, consequentially, unknown interactions with the receiving environments..

· The Applications are defective because they reveal no details of either the transgenic constructs of the new organisms involved, or of any planned scientific commitment to develop effective reporter-gene methodologies to detect and quantify the release and transfer of animal transgenes from GE-livestock hotspots to the natural environment.

· PSGR recommends that Applications GMC07012, GMD07074, GMD08012, DMF07001 and 67A amendment to GMF98009 Part I and II not be approved in perpetuity as all five Applications are directly or indirectly seeking to do.

Proposals for new regulations for the management of genetically modified crops under the Hazardous Substances and New Organisms Act. A response to Cabinet Minutes CBS Min (08) 13/24.

1. PSGR strongly supports improved regulations that bolster biosecurity, and ensure conventional and organic growers and honey producers can continue to grow and market non-GE products without fear of unchecked transgenic contamination. 1.1. It is vital that New Zealand protects its ‘GE free’ and ‘Clean Green’ image that is fundamental to the on-going success of its exports and tourism, and the on-going success of its local food manufacturers meeting the demands of domestic and overseas consumers and customers. It has been well reported that the slightest level of transgenic contamination results in products being rejected. With New Zealand’s overseas customers, this can be a particularly costly experience for businesses.1.2. PSGR welcomes an initiative that would ensure conventional and organic growers, honey producers, and domestic manufacturers, have an assurance about the integrity and marketability of their products and, with local community councils, freedom from responsibility for inadvertent transgenic contamination.

2. PSGR welcomes this opportunity to improve legislation in respect of GMOs. However, before any releases of GMOs occur, we strongly advocate that each formal application to ERMA that seeks controlled release of a GMO should be required to provide complete scientific documentation of the intrinsic design of each new genetic-construct that enables its detection and identification during relevant HGT and LGT monitoring activities carried out under field conditions. No conditional release approval should be granted by ERMA without the applicant first providing ERMA with this necessarily relevant bio-security information.

3. PSGR also proposes:(a) Provision of a greater regulatory level of transparency, accountability and public openness in the management of GMOs in New Zealand. (b) Rigorous control of any release, including strict conditions for monitoring and auditing. Any release should be restricted to proscribed, controlled growing areas, and not released onto the open market.(c) Rigorous, effective legislation to ensure that a domestic liability regime effectively addresses accountability and redress for transgenic contamination including penalties for negligence, nuisance and breach of statutory compliance. This accountability and redress lies with the developer, seed supplier, transporter, and grower, and not with local growers or beekeepers, local councils, or NZ food manufacturers. Transgenic contamination should not be a fiscal drain or create a health risk to society.(d) Every New Zealander has the basic human right to have the choice of consuming GE-free foods, and for every conventional or organic grower or producer, beekeeper, and food manufacturer to maintain the right to grow or produce clearly labelled and defined products free of transgenes.

4. PSGR proposes that an acceptable standard of segregation to New Zealand growers and businesses should mandatorily involve public and independent debate and scrutiny on a case-by-case basis. Such a standard should be designed to achieve no detectable contamination of any conventional crop, any processed product, or any non-transgenic organism from that area. Applicants should be required to comprehensively and accountably demonstrate that the systems they have in place to meet this standard include the following:(a) Segregation of transgenic plants in the field from any other crops or production in the immediate vicinity, in particular conventional crops and honey production. (b) Not growing any transgenic crop where a conventional crop of the same species is growing in the area, or related to wild relatives growing in that area. (c) Segregation of harvesting and other machinery used in handling or transporting GE crops and processing them; such machinery not being used on non-GE crops or production. (d) Segregation during transport, storage, processing and packing, using storage areas, vehicles and machinery set aside solely for transgenic materials.(e) Disposal of the by-products of GE crops, including containment of debris at harvest time to prevent it being dispersed by wind, rain or thermals; collection of crop-stubble for disposal by on-site incineration, and realistic monitoring for transgene transfer at the GE field site to soil and other local organisms.(f) Clear identification of transgenic livestock and of the boundaries of the land containing them; safe, contained handling and disposal of their waste products while on that land; and regular and realistic monitoring for horizontal gene transfer to soil or other organisms in the immediate vicinity.(g) Clear identification of transgenic animals for the purposes of their transportation, and at sale yards and abattoirs suitably equipped for safe, contained processing or incineration of their waste. (h) Safe, contained handling of GE animal vaccinations containing living transgenic organisms; independent research to find measures that ensure that living transgenic organisms cannot affect other organisms, and to establish whether or not the living organisms can potentially be transferred through faeces to soil and other organisms; and a system to independently test at any stage for the presence of the GMOs in the animals or organisms in the associated area.(i) Safe, contained handling of transgenic fish and seafoods, rather than cages or facilities in open water. Claims regarding triploid fish being sterile have been proven false. (j) There should be unequivocal contractual acceptance by every Applicant to meet all costs associated with developing, implementing and maintaining the above systems. These should be mandatory standards for every Applicant. Had these requirements been in force in 2003, ERMA would have been required to decline GMF03001 (GE Onions field trial: reference GF03001 ERMA Decisions, Section 2.7.3 [specifically 2.7.3.6] on p. 34).

5. PSGR encourages putting in place more stringent and independent regulation and monitoring of genetically modified organisms. Any changes to legislation or regulation should fully address the following primary issues:(a) Protection of the New Zealand environment and indigenous and introduced species from the uncontrolled introduction of transgenes from GMOs. There is ample evidence that transgene containment under field conditions is both problematical and complex.(b) Protection of New Zealand farmers, honey producers, manufacturers and exporters including the expanding and in-demand organic market. Releases and promotions of genetically modified organisms overseas have failed to provide the promised increase in crop yields, reduced use of agricultural chemicals and expansion areas given over to genetically modified crops. Nor has it provided the promised financial returns.(c) Protection of New Zealanders. It is premature to contemplate GMOs entering the food chain or contaminating conventional food sources. The implementation of long- term, independent safety tests on the effects of daily ingestion of a variety of GE foods is conspicuously absent.The advantages claimed by vested interests are short term, and are not in the long-term interests of New Zealand or New Zealanders. Too much emphasis is given to the short-term gains by those with vested interests, and insufficient emphasis given to the long-term effects on society and the environment.

6. PSGR proposes that GMO decision making, regulations and legislation requires a genuinely independent body representative of New Zealand society, comprising individuals who represent a wide range of philosophical backgrounds and disciplines with no affiliations to political parties and industries with vested interests: for example, physicians, scientists and others involved in the science, in epidemiology, and in animal welfare and rights; experts in law and economics; ethicists; interested non-government organizations, and the general public.

7. PSGR supports open, accessible public and publicised registers:(a) Of GMOs approved for field use in New Zealand, and locations where they are being handled or grown;(b) Of locations where there has been a failure to comply with conditional release GMO controls; and(c) Of each location where field contamination from a GMO transgene has been detected and identified.PSGR also proposes that such registers be maintained in perpetuity, together with stringent auditing of compliance requirements.

8. PSGR proposes mandatory labelling for all imported material/s containing GMOs that could be propagated or which could self-replicate. Traceability would apply with labelling at the initial point of production and end at the final consumer. It can be achieved by:(a) More stringent segregation and traceability controls on all GMOs at any point of transfer and usage; (b) Having monitoring facilities available at point of sale;(c) More stringent and extensive examination of imported materials at point of entry into New Zealand.

9. PSGR proposes that the drafted template code of practice for segregation should mandatorily include public and independent as well as industry consultation and input. There should be:(a) Robust, independent management and consultation comprising individuals who represent a wide range of philosophical backgrounds and disciplines without affiliations to political parties or industries with vested interests; (b) A facility for an oversight committee, also comprising individuals who represent a wide range of philosophical backgrounds and disciplines without affiliations to political parties or industries with vested interests; and (c) A facility for government to intervene and overturn decisions, with public consultation in that decision making, where independent oversight finds the decisions inappropriate.

10. PSGR proposes that independent analysis and monitoring of GMO approvals should also be in place to assess liability for the GMO contamination that will occur. Local governments and their communities can utilize the Resource Management Act (RMA) 1991 in the drafting of district plan changes to control GMO applications in their area as is their statutory right. Primary responsibility for the consequences of transgene contamination and redress must lie with the developer, producer, importer and grower of GMOs, not local communities and councils.

11. PSGR also proposes that New Zealand plays an active role in developing an international liability regime in line with the Cartagena Protocol on Biosafety.

12. PSGR proposes that government needs to appoint an independent research team to explore the prevention of secondary or unintended contamination by GMOs, or the unintended or unforeseen field propagation of transgenes through inappropriate field management, and transport and handling, or through medical and veterinary uses of live organisms that find their way into the physical, soil-plant-animal and human environments.

PSGR will not speak to this submission and does not require its details or submission to remain confidential.

Signed by the Trustees of Physicians and Scientists for Responsible Genetics and its members

PSGR recommends that ERMA declines application GMR 07001 for the following five reasons:

1. We believe there is a serious error of entry on page 42, section 4.2, of application GMR07001. Information provided in the application itself, and also information issued by NZRB in the public domain, repeatedly affirms that GMR07001 is an application for “conditional release from containment with controls” for Proteqflu and Proteqflu Te vaccines. Even though the applicants have not sought a specific expiry date, as they also formally declare on page 45 of the application, the HSNO Act (S38) will nevertheless provide a statutory default expiry date of five years (maximum) following the date of any conditional release-decision. It is therefore a serious error of contradiction for this application to have a tick for “full (unconditional) release” in the table on page 42 when the background information provided by the NZRD in the application and released to the public domain clearly supports a “conditional release from containment with controls.”

Summary: On the basis of the seriousness of the contradiction between the applicants’ background statements which clearly support “conditional release from containment with controls” and the ‘yes’ tick to ‘unconditional release’ on page 42, we recommend ERMA declines GMR07001.

2. It may be unintentional, but it is misleading for the NZRB (New Zealand Racing Board) and NZEHA (New Zealand Equine Health Association) in their Application Summary to have readers believe that Proteqflu vaccine was the sole agent responsible for the eradication and control of last year’s equine influenza outbreak in Australia. In reality, the use of this vaccine played a much less dramatic role. It was only one of several management tools used in the post-outbreak recovery process to help restore Australia to equine influenza (EI)-free status.

Professional opinion of Australian veterinarians at the time placed high significance on the reinstatement of effective quarantine procedures whose temporary collapse had allowed the virus to escape in the first place from imported vaccinated horses, probably from Japan (Dr James Gilkerson, president of Equine Veterinarians of Australia and Director of Equine Infectious Disease Lab., University of Melbourne). On the midday ‘Rural Report’ of Radio NZ on Monday 25 June 2008, Dr Gilkerson, who was in Wellington at the time, indicated that vaccination of Australian horses with Proteqflu, the vaccine named in this application to ERMA, would not be allowed to continue and would not be permitted after 30 June 2008.

< http://www.abc.net.au/pm/content/2007/s2089830.htm >

< http://www.thehorse.com/Print/Article.aspx?ID=12140 >

< http://www.horsetalk.co.nz/news/2008/06/102.shtml >

Summary: Proteqflu vaccine is likely to become known internationally as the EI vaccine withdrawn by Australia because it is no longer regarded a biosecurity tool. This is a second reason why ERMA should decline GMR07001.

3. The applicants make a further claim that they regard “vaccination with Proteqflu and Proteqflu Te as an essential tool to prevent enormous losses to the [NZ] equine industry.” Although New Zealand remains an equine influenza-free country, three other EI-vaccines are currently registered with Biosecurity NZ (MAFBNZ) for specified use in ‘emergencies.’ The most recent is a live vaccine, FluAvert I.N., which ERMA granted approval for release only a few months ago (December 2007). MAFBNZ and NZRB (with Intervet of the Netherlands) have contracted between them to supply 120,000 doses of vaccine for use ‘in emergencies’ in NZ. It is utterly presumptuous for NZRB (this application) to seek approval of a fourth “essential tool” (specifically Proteqflu and Proteqflu Te) when the existing MAFBNZ toolbox already contains three approved and registered vaccines for use in New Zealand, together with on-going contracts established to supply them.

Summary: We do not believe that Proteqflu and Proteqflu Te qualify as essential biosecurity components for the MAFBNZ EI-vaccine toolbox that already contains three approved and registered-for-use EI-vaccines. This is a third reason why we recommend that ERMA declines GMR07001.

4. Only a few months ago (20 December 2007), ERMA approved an application (from MAFBNZ) for the controlled release of FluAvert I.N., (a live intranasal vaccine) as a biosecurity tool to control possible equine influenza (EI) in New Zealand. Only two months earlier (October), the NZRB was briefed by MAFBNZ that one of the currently registered EI-vaccines (Equilis IPA by Intervet) was undergoing replacement with Prequenza, a sterile EI vaccine preparation administered by intramuscular (IM) injection. Prequenza is described as having vaccine characteristics and performance almost identical with Proteqflu, the vaccine named in the present application (GMR 07001). Biosecurity NZ has clearly established it already has three “essential” biosecurity tools against EI registered previously for use in NZ, none of which is based on a transgenic viral platform that is the basis of Proteqflu now withdrawn in Australia.

Summary: At least one of the currently registered EI-vaccines in MAFBNZ’s tool box, Prequenza, has features that are at least the equal of Proteqflu. We recommend that ERMA decline this application.

5. Application GMR07001 claims that horses vaccinated with Proteqflu show an immunising effect that is reduced to a “third of the time of any other vaccine.“ Our reading of the technical data for Proteqflu, is that low levels of haemaglutinin-antibodies that appear a few days following vaccination have been mistakenly interpreted by the applicants to be an “immunising effect.” Such responses may not genuinely indicate that such animals have acquired sufficient immunity to withstand live EI viral-challenge.

In contrast, the technical data for Prequenza (a vaccine that supersedes Equilis IPA, and whose details are well known to MAFBNZ) indicates that actual viral protection (not just detection of antibodies) determined by strain specific EI-challenge procedures can be observed by 14 days, with full protection after 4 weeks lasting for up to 12 months. This is the sort of ‘essential tool’ characteristic that should be desired by the applicant.

Any vaccination schedule involving horses for export, or temporary export, is likely to fall well within the time-frame normally set aside for customary pre-export animal preparation. In any event, for NZ horses specifically being lined up for export to Australia, vaccination with Proteqflu as a requirement of entry is no longer presumed to be necessary.

Summary: For several reasons, such as the five outlined above, there appear to be no substantial grounds for ERMA to conclude it should approve Proteqflu as the ‘essential tool’ for emergencies as claimed by NZRB and NZEHA, or even that it has the desirable features of a biosecurity tool. These reasons underscore our recommendation that ERMA declines approval of application GMR07001.

PSGR will not speak to this submission.

Compiled by A Neil Macgregor PhD on behalf of PSGR.

Dr A Neil Macgregor is a biological scientist with primary expertise in soil biology and biochemistry, soil microbial ecology, and microbial genetics. He graduated BSc and MSc from the University of Otago in 1961, and PhD from Cornell University (USA) in 1968. He has held teaching and research positions at universities in several countries and Massey University, Palmerston North (Tiritea Campus) from 1991 until his retirement in1999. His specific research interests and on-going major interests include work on vaccines and animal health.

Signed by the Trustees of Physicians and Scientists for Global Responsibility